Study identifier:D7250C00001
ClinicalTrials.gov identifier:NCT06381466
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase I, Randomized, Single blinded, Placebo-controlled Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD0233 Following Single and Multiple Ascending Dose Administration in Healthy Male and Female Participants 18 to 50 years of age.
Dilated cardiomyopathy
Phase 1
Yes
AZD0233, AZD0233 Placebo
All
96
Interventional
18 Years - 50 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Sequential Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Oct 2024 by AstraZeneca
AstraZeneca
PAREXEL
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Part A (SAD): Cohort 1A - AZD0233 (dose 1) Healthy participants will receive AZD0233 (dose 1) orally as a single ascending dose. | Drug: AZD0233 Randomized participants will receive AZD0233 orally as a single ascending dose (dose 1, dose 2, dose 3, dose 4 or dose 5) or multiple ascending dose (dose 6, dose 7 or dose 8) |
Experimental: Part A (SAD): Cohort 2A - AZD0233 (dose 2) Healthy participants will receive AZD0233 (dose 2) orally as a single ascending dose. | Drug: AZD0233 Randomized participants will receive AZD0233 orally as a single ascending dose (dose 1, dose 2, dose 3, dose 4 or dose 5) or multiple ascending dose (dose 6, dose 7 or dose 8) |
Experimental: Part A (SAD): Cohort 3A - AZD0233 (dose 3) Healthy participants will receive AZD0233 (dose 3) orally as a single ascending dose. | Drug: AZD0233 Randomized participants will receive AZD0233 orally as a single ascending dose (dose 1, dose 2, dose 3, dose 4 or dose 5) or multiple ascending dose (dose 6, dose 7 or dose 8) |
Experimental: Part A (SAD): Cohort 4A - AZD0233 (dose 4) Healthy participants will receive AZD0233 (dose 4) orally as a single ascending dose. | Drug: AZD0233 Randomized participants will receive AZD0233 orally as a single ascending dose (dose 1, dose 2, dose 3, dose 4 or dose 5) or multiple ascending dose (dose 6, dose 7 or dose 8) |
Experimental: Part A (SAD): Cohort 5A - AZD0233 (dose 5) Healthy participants will receive AZD0233 (dose 5) orally as a single ascending dose. | Drug: AZD0233 Randomized participants will receive AZD0233 orally as a single ascending dose (dose 1, dose 2, dose 3, dose 4 or dose 5) or multiple ascending dose (dose 6, dose 7 or dose 8) |
Experimental: Part B (MAD): Cohort 1B - AZD0233 (dose 6) Healthy participants will receive AZD0233 (dose 6) orally as a multiple ascending dose. | Drug: AZD0233 Randomized participants will receive AZD0233 orally as a single ascending dose (dose 1, dose 2, dose 3, dose 4 or dose 5) or multiple ascending dose (dose 6, dose 7 or dose 8) |
Experimental: Part B (MAD): Cohort 2B - AZD0233 (dose 7) Healthy participants will receive AZD0233 (dose 7) orally as a multiple ascending dose. | Drug: AZD0233 Randomized participants will receive AZD0233 orally as a single ascending dose (dose 1, dose 2, dose 3, dose 4 or dose 5) or multiple ascending dose (dose 6, dose 7 or dose 8) |
Experimental: Part B (MAD): Cohort 3B - AZD0233 (dose 8) Healthy participants will receive AZD0233 (dose 8) orally as a multiple ascending dose. | Drug: AZD0233 Randomized participants will receive AZD0233 orally as a single ascending dose (dose 1, dose 2, dose 3, dose 4 or dose 5) or multiple ascending dose (dose 6, dose 7 or dose 8) |
Placebo Comparator: Part A (SAD): Placebo cohort Healthy participants will receive placebo orally as a single ascending dose. | Drug: AZD0233 Placebo Randomized participants will receive matching placebo orally as a SAD or MAD. Other Name: Placebo |
Placebo Comparator: Part B (MAD): Placebo cohort Healthy participants will receive placebo orally as a multiple ascending dose. | Drug: AZD0233 Placebo Randomized participants will receive matching placebo orally as a SAD or MAD. Other Name: Placebo |
Experimental: Part A (SAD): Food Effect (FE) extended Cohort 3A Healthy participants from Cohort 3A will participate in this extended cohort after a washout period of 24 hours. | Drug: AZD0233 Randomized participants will receive AZD0233 orally as a single ascending dose (dose 1, dose 2, dose 3, dose 4 or dose 5) or multiple ascending dose (dose 6, dose 7 or dose 8) |